Drugs / Levoleucovorin
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Levoleucovorin

Developed for
colorectal cancer · gastric adenocarcinoma · gastric cancer · gastroesophageal junction adenocarcinoma · hepatocellular carcinoma · autism spectrum disorder · esophageal squamous cell carcinoma · language disorder
+26 more · rectal cancer · rectal neoplasm · ampulla of vater cancer · biliary tract cancer · cholangiocarcinoma · colon carcinoma · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · colonic neoplasm · colorectal neoplasm · esophageal cancer · gallbladder cancer · gastroesophageal adenocarcinoma · malignant colon neoplasm · malignant pancreatic neoplasm · metastatic malignant neoplasm in the colon · metastatic neoplasm · neuroendocrine carcinoma · non-small cell lung carcinoma · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · rectal carcinoma · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · gastric neoplasm · peritoneal carcinomatosis
Investigated by
Fujian Cancer Hospital · Merck Sharp & Dohme LLC · China Medical University, China · Acrotech Biopharma Inc. · Gruppo Oncologico del Nord-Ovest · National Cancer Center Hospital East
+38 more · Southwest Autism Research & Resource Center · State University of New York - Downstate Medical Center · Wyeth is now a wholly owned subsidiary of Pfizer · Amgen · Asan Medical Center · Autism Speaks · Azienda Ospedaliero, Universitaria Pisana · Cancer Research UK · Centre Oscar Lambret · Centro Ricerche Cliniche di Verona · Daiichi Sankyo · Foundation Medicine · Grupo Espanol Multidisciplinario del Cancer Digestivo · Hiroshima Prefectural Hospital · Hoffmann-La Roche · Hokkaido Gastrointestinal Cancer Study Group · Institute of Cancer Research, United Kingdom · Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Jiangsu Hengrui Pharmaceutical Co., Ltd. · John Hays · Kyungpook National University Hospital · National Cancer Center, Korea · National Cancer Institute, Naples · National Hospital Organization Shikoku Cancer Center · Ono Pharmaceutical Co., Ltd. · Sanofi · Seagen Inc. · Servier · Spanish Group for Research in Neuroendocrine Tumors · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sun Yat-sen University · The Christie NHS Foundation Trust · The First Hospital of Jilin University · Tianjin Medical University Cancer Institute and Hospital · Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · United States Department of Defense · Wen Li · Yu jiren

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) FUSILEV 2011-04-29 fda.gov
Approved US (FDA) FUSILEV 2008-03-07 fda.gov

Trials 42 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT06538207 Jan 2021 → Oct 2024 malignant pancreatic neoplasm Ono Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT01820091 Apr 2013 → Apr 2015 non-small cell lung carcinoma Acrotech Biopharma Inc. Withdrawn No outcome recorded
Phase 1 NCT01789723 Mar 2013 → Mar 2015 non-Hodgkin lymphoma Acrotech Biopharma Inc. Withdrawn No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT06780111 Jul 2025 → Jan 2032 expected esophageal squamous cell carcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT06469944 Sep 2024 → Sep 2029 expected esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal junction adenocarcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT06428409 Jun 2024 → Oct 2029 expected biliary tract cancer, colorectal cancer, pancreatic ductal adenocarcinoma Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1/2 NCT05319639 Feb 2023 → Oct 2024 overdue gastric cancer Fujian Cancer Hospital Recruiting No outcome recorded
Phase 229 trials
Phase 2 NCT07621497 Jun 2026 → Jun 2029 expected metastatic malignant neoplasm in the colon Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07061080 Dec 2025 → Dec 2028 expected neuroendocrine carcinoma Spanish Group for Research in Neuroendocrine Tumors Recruiting No outcome recorded
Phase 2 NCT07559760 Nov 2025 → May 2027 expected colorectal cancer The First Hospital of Jilin University Recruiting No outcome recorded
Phase 2 NCT07119931 Sep 2025 → Dec 2027 expected hepatocellular carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07018570 Jul 2025 → Jun 2030 expected gastroesophageal junction adenocarcinoma National Cancer Center Hospital East Recruiting No outcome recorded
Phase 2 NCT06607107 Feb 2024 → Jan 2026 overdue hepatocellular carcinoma Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting No outcome recorded
Phase 2 NCT06197438 Jan → Apr 2024 gastric cancer Fujian Cancer Hospital Unknown No outcome recorded
Phase 2 NCT05062889 May 2023 → Oct 2027 malignant colon neoplasm Gruppo Oncologico del Nord-Ovest Suspended No outcome recorded
Phase 2 NCT05715931 Feb 2023 → Mar 2025 overdue gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Yu jiren Recruiting No outcome recorded
Phase 2 NCT05797883 Aug 2022 → Dec 2023 colorectal cancer China Medical University, China Unknown No outcome recorded
Phase 35 trials
Phase 3 NCT06509126 Jun 2024 → Jan 2028 expected colorectal cancer National Cancer Institute, Naples Recruiting No outcome recorded
Phase 3 NCT01926236 Feb 2014 → Jan 2018 ampulla of vater cancer, cholangiocarcinoma, gallbladder cancer The Christie NHS Foundation Trust Completed No outcome recorded
Phase 3 NCT00195585 Oct 2002 → Feb 2006 colon carcinoma Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00195572 May 2002 → Aug 2008 gastric cancer Wyeth is now a wholly owned subsidiary of Pfizer Completed No outcome recorded
Phase 3 NCT00005586 Oct 1997 → ? colorectal cancer Institute of Cancer Research, United Kingdom Completed No outcome recorded
Phase not applicable1 trial
NCT04174339 Dec 2019 → Dec 2020 gastric adenocarcinoma Fujian Cancer Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 79 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 113 trials
Phase 1 NCT05546853 Background Mar 2023 → Dec 2024 pancreatic ductal adenocarcinoma University Hospital, Grenoble Completed No outcome recorded
Phase 1 NCT05087992 Background Nov 2021 → Oct 2023 digestive system cancer Boehringer Ingelheim Completed No outcome recorded
Phase 1 NCT06540261 Background Sep 2021 → Dec 2027 expected colorectal cancer Ono Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT06532344 Background Jul 2021 → Dec 2026 expected malignant pancreatic neoplasm Ono Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT06547385 Background Jan 2021 → Oct 2027 expected colorectal cancer Ono Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT05609370 Background Jan 2023 → May 2025 overdue colorectal cancer BeiGene Active not recruiting No outcome recorded
Phase 1/2 NCT03294252 Background May 2017 → Feb 2019 digestive system cancer Institut Cancerologie de l'Ouest Terminated No outcome recorded
Phase 1/2 NCT01681472 Comparator Sep 2012 → Aug 2013 colonic neoplasm Isofol Medical AB Completed No outcome recorded
Phase 1/2 NCT01611857 Background Jul 2012 → Jul 2015 gastroesophageal cancer SCRI Development Innovations, LLC Completed No outcome recorded
Phase 232 trials
Phase 2 NCT07381400 Background Feb 2026 → Feb 2028 expected rectal cancer Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Phase 2 NCT06790706 Background Oct 2025 → Nov 2028 expected carcinoid tumor, digestive system neuroendocrine neoplasm, gestational trophoblastic neoplasm, peritoneal mesothelioma +2 Hospices Civils de Lyon Active not recruiting No outcome recorded
Phase 2 NCT07124884 Background Aug 2025 → Jun 2030 expected acute myeloid leukemia, KRAS gene mutation, colorectal carcinoma Federation Francophone de Cancerologie Digestive Not yet recruiting No outcome recorded
Phase 2 NCT06317662 Background Jun 2025 → Dec 2028 expected B-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 2 NCT06757244 Background Feb 2025 → Feb 2028 expected pancreatic neoplasm Hopital Foch Recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT06509880 Comparator Jul 2022 → Jul 2023 MIPO Clinic Completed No outcome recorded
Phase 2/3 NCT05179889 Background Jul 2021 → Jul 2028 expected malignant colon neoplasm Chungnam National University Hospital Recruiting No outcome recorded
Phase 2/3 NCT03686254 Comparator Jul 2018 → Oct 2023 colorectal cancer Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Phase 324 trials
Phase 3 NCT07582315 Comparator Jul 2026 → Dec 2028 expected biliary tract cancer Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07676162 Background Jul 2026 → Sep 2029 expected colorectal cancer Suzhou Suncadia Biopharmaceuticals Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07606599 Comparator May 2026 → Dec 2028 expected biliary tract cancer Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06793917 Background Jun 2025 → Apr 2028 expected gastric cancer Fujian Cancer Hospital Recruiting No outcome recorded
Phase 3 NCT06750094 Background Dec 2024 → Dec 2027 expected colorectal neoplasm Janssen Research & Development, LLC Recruiting No outcome recorded
Phase not applicable3 trials
NCT05601323 Background Jan 2023 → May 2027 expected pancreas disorder SONIRE Therapeutics Inc. Active not recruiting No outcome recorded
NCT03904043 Background Jul 2020 → Aug 2024 rectum adenocarcinoma Washington University School of Medicine Completed No outcome recorded
NCT03045770 Background Feb 2017 → Dec 2019 gastroesophageal junction adenocarcinoma Fujian Cancer Hospital Unknown No outcome recorded

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 121 sources stand behind the page.

FieldValueCited text
Known as levoleucovorin “This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m\^2) or racemic leucovorin 400 mg/m\^2, oxaliplatin 85 mg/m\^2, bolus 5-fluorouracil 400 mg/m\^2,...” NCT02468557
43

“Forty-one participants will receive the treatment NALIRIFOX (liposomal irinotecan, 5-fluorouracil, levoleucovorin and oxaliplatin) until progression or unacceptable toxicity.” PMID 39987459 Feb 2025

“200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours.” NCT01652196

“5-fluorouracil \[continuous infusion\], leucovorin \[administered IV\] (or levoleucovorin \[administered IV\]), and oxaliplatin \[administered IV\]” NCT04952753

“Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours” NCT05673772

“in combination with leucovorin or levoleucovorin (LV) IV administered per local guidelines and/or prescribing information once every 2 weeks” NCT05609370

“The LV5FU2 regimen includes folinic acid (400 mg/m², or 200 mg/m² if levo-leucovorin is used) as a two-hour IV infusion” NCT07124884

“Leucovorin 400 mg/m² IV infusion over 120 minutes, or 200 mg/m² levo-leucovorin if leucovorin is unavailable” NCT03343301

“Levofolinic Acid For Injection is the first approved class 2.1 sodium levoleucovorin formulation in China.” NCT07621497

“oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion” NCT00609622

“Leucovorin day 1 every 14 days. Levoleucovorin may be substituted if leucovorin is not available.” NCT03904043

“Leucovorin 200 mg/m² or Levoleucovorin 100 mg/m², IV on day 1 of each 14 day cycle;” NCT05715931

“concurrent with leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2) IV infusion” NCT06509880

“leucovorin 400 mg/m\^2 or levoleucovorin 200 mg/m\^2 IV on Day 1” NCT02563002

Levoleucovorin 200 mg/m² via arterial infusion over 1-2 hours” NCT07119931

levoleucovorin \[10 mg/mL concentration; administered IV\]” NCT03798626

“substitution with levo-leucovorin 200 mg/m2 IV is allowed” NCT03597581

“200 mg/m² levo-leucovorin if leucovorin is unavailable” NCT03694522

“Leucovorin 400 (or levoleucovorin 200) mg/m2 IV day 1” NCT05179889

Levoleucovorin 200 mg/m², intravenous infusion” NCT07381400

levoleucovorin: 200 mg/m2” NCT05087992

LevoleucovorinNCT01611857

NCT05319639

NCT00865709

NCT05839470

NCT04210115

NCT06750094

NCT06780111

NCT07676162

NCT04456699

NCT06793917

NCT06662786

NCT03698461

NCT03007147

NCT06197438

NCT06469944

NCT06428409

NCT03222089

NCT01681472

NCT04662710

NCT05945823

NCT06317662

NCT05253651

NCT04949256

Known as Calcium levofolinate “Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment...” NCT03301454
17

“The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400...” NCT05768503

“mFOLFOX7(Oxaliplatin 85mg/m2, Calcium Levofolinate 200mg/m2, Fluorouracil 400 mg/m2 D1,2400mg/m2 maintain 46 hours,) combined with Apatinib and Camrelizumab 200mg every 3 weeks.” NCT06607107

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT03244774

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT02697838

“The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT04121039

“folinic acid 400 mg/m2 or calcium levofolinate 200 mg/m2 given as a 2-h IV infusion” NCT06757244

“followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).” NCT03788174

“Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1” NCT03686254

calcium levofolinate, 200 mg/m2 infusion for 1 hours” NCT05582278

“and Calcium Levofolinate (200 mg/m2)” NCT03707639

Calcium Levofolinate (200 mg/m2)” NCT04174339

NCT07582315

NCT05546853

NCT04776655

NCT03045770

NCT07606599

NCT02697058

Known as Calcium Levofolinate Hydrateb ClinicalTrials.gov intervention name — accepted as the source's own label NCT06547385
Known as Fusilev ClinicalTrials.gov intervention name — accepted as the source's own label NCT01820091
1

NCT01789723

Known as Fusilev - (Levoleucovorin) Fusilev - (Levoleucovorin)NCT01789723
Known as Isovorin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00316745
3

NCT00195585

NCT00195572

NCT01524094

Known as l-folinic acid “oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion” NCT05712356
7

“Folinic acid: 400 mg/m² intravenous over 30 minutes or L-folinic acid (racemic form L) 200 mg/m² over 30 minutes” NCT03719924

“FOLFIRI: 200 mg L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion” NCT05312398

L-Folinic acid 100 mg/m2 IV infusion of 2 hours” NCT01878422

L-folinic acid 200 mg/m2 IV” NCT06790706

NCT06509126

NCT01926236

NCT03294252

Known as l-Leucovorin “Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer” NCT00631410
16

l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.” NCT01276379

“* FOLFOX4:Oxaliplatin 85 mg/m2. l-Leucovorin 100 mg/m2 5-fluorouracil 400/600 mg/m2.” NCT02934464

L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1” NCT03635021

L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1” NCT03487939

L-LEUCOVORIN 200 mg/m\^2 IV over 2-h, day 1” NCT03484221

L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1” NCT03085992

L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1” NCT02271464

L-Leucovorin 200 mg/m\^2 IV over 2h, day 1” NCT03484195

NCT00668863

NCT00209703

NCT03721653

NCT03231722

NCT00005586

NCT04513951

NCT05062889

NCT06219941

Known as l-LV “Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer” NCT00209703
3

“oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab” NCT02337946

“oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab” NCT02394795

“Levofolinate calcium (l-LV)” NCT02497157

Known as Leucosodium “Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2” NCT05673772
Known as Leucovroin “Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2” NCT05673772
Known as Levofolinate “Patients were randomly assigned (1:1; block size of three), without stratification, to receive FOLFIRI (irinotecan 180 mg/m2, calcium folinate 400 mg/m2 or levofolinate 200...” PMID 36739879 Feb 2023
11

“400 mg/m2 folinic acid or 200 mg/m² levofolinate in a 2-h infusion” NCT07061080

“Nanoliposomal irinotecan, Fluorouracil, LevofolinateNCT05601323

Levofolinate 100 mg/m2 iv: day 1-2” NCT02000050

NCT01882868

NCT01286818

NCT04745988

NCT06532344

NCT07018570

NCT02641873

NCT06540261

NCT06538207

Known as levofolinate calcium ClinicalTrials.gov intervention name — accepted as the source's own label NCT02394795
2

NCT02497157

NCT02337946

Known as Levofolinic acid “Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen” NCT01111604
9

“followed by levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus.” NCT04310176

Levofolinic Acid 200mg/m² continuous mixed infusion” NCT05797883

NCT01590719

NCT01383707

NCT06041477

NCT07559760

NCT01718873

NCT03528785

NCT01481545

Known as Levofolinic Acid For Injection Levofolinic Acid For Injection is the first approved class 2.1 sodium levoleucovorin formulation in China.” NCT07621497
Known as Levoleucovorin Calcium ClinicalTrials.gov intervention name — accepted as the source's own label NCT04060030
1

NCT04060017

Known as LFA “Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen” NCT01111604
Known as Zuoyu “Levofolinic Acid (Zuoyu ®)” NCT05797883
Route Intravenous “patients receive L-leucovorin IV followed by fluorouracil IV” NCT00005586